In short

A first-in-human clinical trial using Boston Scientific’s IntellaTip MiFi™ XP Ablation Catheter for the treatment of type 1 atrial flutter has been completed in Australia.

Background

Atrial flutter is a common arrhythmia originating in the right atrium of the heart and affects nearly one million people in the United States. Patients with type 1 atrial flutter may exhibit symptoms that include palpitations, shortness of breath, fatigue, lightheadedness and fainting. Catheter ablation has become a first-line treatment approach for patients with recurrent type 1 atrial flutter and demonstrates more successful short- and long-term outcomes compared to anti-arrhythmic drug therapy.

Boston’s IntellaTip MiFi XP Catheter is designed to provide physicians with high resolution, precise, multidimensional information through sophisticated micro-sensors at the tip of the catheter.

This single center feasibility trial enrolled 10 patients and was led by Prash Sanders , MBBS, PhD, FHRS, director of the Centre for Heart Rhythm Disorders at the University of Adelaide and the Royal Adelaide Hospital. From his comments it would appear the small study went well, although in its press release Boston Scientific did not provide detailed data.

Investigator comments

“The IntellaTip MiFi XP Catheter provided all of the benefits of a large tip catheter while allowing significantly more detailed mapping,” said Professor Sanders. “The catheter handling was intuitive and I found that the mapping capabilities gave me greater ability to identify gaps and know where to ablate. Potentially reflecting this, we had several procedures where the ablation time was quite short compared to conventional ablation technology.”

Company comments

“We believe the design of the IntellaTip MiFi technology will redefine the quality of critical electrical information that electrophysiologists depend on during ablation procedures,” said Pete Sommerness , general manager, Electrophysiology, Boston Scientific. “This technology demonstrates our commitment to providing electrophysiologists with innovative solutions to help improve the health of patients around the world.”

Regulatory status

The IntellaTip MiFi XP is an investigational device and is not available for sale in the United States.